Product Safety Recalls

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Nobel Biocare Usa Llc Recall 89465

Description: NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R

Nobel Biocare Usa Llc Recall 89465 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0658-2022
Event ID89465
Event DescriptionNobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
Product TypeDevices
DistributionWorldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, MA, ME, MI, MN, MS, NC, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA and WI. The countries of Canada, Mexico and Turkey.
Quantity702 pieces
Recall ReasonDue to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the implants. As a result, this could potentially lead to aborted or a delay in surgical procedure.
Device Classification20220302
Device Code InfoCatalog Number: 36707 UDI Code: (01)07332747160529(10)13116495(11)210720(17)260618; (01)07332747160529(10)13116496(11)210720(17)260618; (01)07332747160529(10)13116497(11)210720(17)260618; Lot Numbers: 13116495, 13116496, 13116497
Center Classification Date20220218
Recall Initiation Date20211217
Recalling FirmNobel Biocare Usa Llc
Initial Notification Letter
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